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← BIZENGRI: unresectable metastatic Non-small cell lung cancer after prior therapy

NCT02062632 · STUDY IN CONTEXT

Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

exploratory · NOT_POSTED

Means and proportions, along with 95% confidence intervals and plots over time will be reported for adverse event levels by week.

Source null

→

exploratory · NOT_POSTED

Means and proportions, along with 95% confidence intervals and plots over time will be reported for pain levels by week.

Source null

→

primary · POSTED

Average Area Under the Curve per assessment (aAUCpa) of pain for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment. Patients will assess their pain at baseline and at 5, 15, 30, 60, 120, and 240 minutes after treatment. The AUC calculation is based on the assessment number (1,2,3,4,5,6) instead of the actual number of minutes (5,15,30,60,120,240). This results in an AUC measure that is the average pain score across all of the measurements and is not a function of the number of minutes from treatment. The area under the curve of these 6 time points will be adjusted by their baseline pain score. The pain scores at each time point are given equal weights in the AUC calculation and the AUC calculation does not use the number of minutes after treatment. Therefore, the AUC measurement scale is the same as the original pain score scale.

5 were accrued but only 3 provided data. Since only 1 patient was accrued \& completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) \& only for placebo intervention.

→

secondary · POSTED

Incidence of any grade 3 or higher adverse events using Common Terminology Criteria for Adverse Events (CTCAE). Number or patients reporting a grade 3 or higher adverse event according to CTCAE

5 were accrued but only 3 provided data. Since only 1 patient was accrued \& completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) \& only for placebo intervention.

→

secondary · POSTED

Subgroup analyses will be performed to determine differential effects within the two stratification factors.

Only patients who submitted data on alternative analgesics are evaluable for this outcome measure. None of the patients provided information about alternative analgesics, so this secondary outcome could not be analyzed.

→

secondary · POSTED

Patient Preference for Continued Therapy at Initial Dose and Crossover

Only patients who submitted data on patient preference are evaluable for this outcome measure. Since none of the patients crossed over to the optional phase of the study, this secondary outcome could not be analyzed.

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

FACT · Use of Alternative Analgesics

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT02062632
qol key
qol-0002
source section id
NCT02062632-om-0002
source outcome index
2
instrument
FACT
instrument basis
matched 'factors' in the study's own wording
scale title
Use of Alternative Analgesics
measure definition
Subgroup analyses will be performed to determine differential effects within the two stratification factors.
time frame
Up to 4 hours after treatment
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Only patients who submitted data on alternative analgesics are evaluable for this outcome measure. None of the patients provided information about alternative analgesics, so this secondary outcome could not be analyzed.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Patient-reported symptom or function measure · Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events, Radiation Therapy Oncology Group, and Patient Reported Outcomes (Continuation Phase)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT02062632
qol key
qol-0004
source section id
NCT02062632-om-0004
source outcome index
4
instrument
Patient-reported symptom or function measure
instrument basis
matched 'patient reported' in the study's own wording
scale title
Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events, Radiation Therapy Oncology Group, and Patient Reported Outcomes (Continuation Phase)
measure definition
Means and proportions, along with 95% confidence intervals and plots over time will be reported for adverse event levels by week.
time frame
Up to 3 months
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Unnamed quality-of-life measure · Quality of Life Using European Organization for Research and Treatment of Cancer Quality of Life-Lung Cancer 13 and Functional Assessment of Cancer Therapy-Lung

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT02062632
qol key
qol-0006
source section id
NCT02062632-om-0006
source outcome index
6
instrument
Unnamed quality-of-life measure
instrument basis
matched 'quality of life' in the study's own wording
scale title
Quality of Life Using European Organization for Research and Treatment of Cancer Quality of Life-Lung Cancer 13 and Functional Assessment of Cancer Therapy-Lung
measure definition
Comparative statistics will be used to explore the relationship between quality of life and radiation-induced thoracic toxicities. These analyses will include scatterplots, spearman correlations, t-tests and chi-square tests.
time frame
Up to 4 hours after treatment
analysis role
exploratory
reporting status
NOT_POSTED
higher is better
Source null
direction quote
Source null
population note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-non-small-cell-lung-cancer-bizengri-c0e986a8
nct id
NCT02062632
trial label
Doxepin Hydrochloride in Treating Esophageal Pain in Patients With Thoracic Cancer Receiving Radiation Therapy to the Thorax With or Without Chemotherapy
applicability
unclear
applicability note
Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
1
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    outcome key
    om-0004
    source section id
    NCT02062632-om-0004
    source outcome index
    4
    endpoint
    Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events, Radiation Therapy Oncology Group, and Patient Reported Outcomes (Continuation Phase)
    endpoint definition
    Means and proportions, along with 95% confidence intervals and plots over time will be reported for adverse event levels by week.
    time origin
    Up to 3 months
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    outcome key
    om-0005
    source section id
    NCT02062632-om-0005
    source outcome index
    5
    endpoint
    Pain Levels (Continuation Phase)
    endpoint definition
    Means and proportions, along with 95% confidence intervals and plots over time will be reported for pain levels by week.
    time origin
    Up to 3 months
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    data cutoff
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    outcome key
    om-0000
    source section id
    NCT02062632-om-0000
    source outcome index
    0
    endpoint
    Change in Mouth Pain as Measured by Average Area Under the Curve Per Assessment
    endpoint definition
    Average Area Under the Curve per assessment (aAUCpa) of pain for the first cycle of treatment. Scores are reported on a 0-100 scale, where 100=better outcome QOL. The aAUCpa is the average of each AUC between each sequential assessment. Patients will assess their pain at baseline and at 5, 15, 30, 60, 120, and 240 minutes after treatment. The AUC calculation is based on the assessment number (1,2,3,4,5,6) instead of the actual number of minutes (5,15,30,60,120,240). This results in an AUC measure that is the average pain score across all of the measurements and is not a function of the number of minutes from treatment. The area under the curve of these 6 time points will be adjusted by their baseline pain score. The pain scores at each time point are given equal weights in the AUC calculation and the AUC calculation does not use the number of minutes after treatment. Therefore, the AUC measurement scale is the same as the original pain score scale.
    time origin
    Baseline and 5, 15, 30, 60, 120, and 240 minutes after treatment on day 1
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    5 were accrued but only 3 provided data. Since only 1 patient was accrued \& completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) \& only for placebo intervention.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    outcome key
    om-0001
    source section id
    NCT02062632-om-0001
    source outcome index
    1
    endpoint
    Incidence of Any Grade 3 or Higher Adverse Events Using Common Terminology Criteria for Adverse Events (CTCAE)
    endpoint definition
    Incidence of any grade 3 or higher adverse events using Common Terminology Criteria for Adverse Events (CTCAE). Number or patients reporting a grade 3 or higher adverse event according to CTCAE
    time origin
    Up to 4 hours after treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    5 were accrued but only 3 provided data. Since only 1 patient was accrued \& completed the study on 1 arm, patient confidentiality prevents the reporting of results per intervention. 2nd crossover was optional; none chose to crossover. The study results are only reported for the 1st study period (before crossover) \& only for placebo intervention.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    outcome key
    om-0002
    source section id
    NCT02062632-om-0002
    source outcome index
    2
    endpoint
    Use of Alternative Analgesics
    endpoint definition
    Subgroup analyses will be performed to determine differential effects within the two stratification factors.
    time origin
    Up to 4 hours after treatment
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only patients who submitted data on alternative analgesics are evaluable for this outcome measure. None of the patients provided information about alternative analgesics, so this secondary outcome could not be analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    outcome key
    om-0003
    source section id
    NCT02062632-om-0003
    source outcome index
    3
    endpoint
    Patient Preference for Continued Therapy at Initial Dose and Crossover
    endpoint definition
    Patient Preference for Continued Therapy at Initial Dose and Crossover
    time origin
    At initial Day 1 dose and Day 3 crossover dose.
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Only patients who submitted data on patient preference are evaluable for this outcome measure. Since none of the patients crossed over to the optional phase of the study, this secondary outcome could not be analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Placebo
    regimen
    Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02062632-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Placebo
    regimen
    Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02062632-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Placebo
    regimen
    Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02062632-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Placebo
    regimen
    Patients receive placebo oral solution (swish, gargle for 30 seconds, and slowly swallow) on day 1.
    analyzed count
    0
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02062632-om-0003#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    harm key
    EG000
    source section id
    NCT02062632-ae
    event group key
    EG000
    event group label
    Placebo
    serious affected
    0
    serious at risk
    3
    other affected
    2
    other at risk
    3
    frequency threshold
    0
    collection period
    Up to 4 hours after treatment on day 3
    event definition
    Since only one patient was accrued and completed the study on one arm, patient confidentiality prevents the reporting of results per intervention. Therefore, the study results are only reported for the first study period (before crossover) and only for a single intervention (placebo).Serious AE (SAE) reports may include any serious or non-serious events considered related to the primary event; collectively, these events are referred to as Expedited AEs, \& appear in the SAE table.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    qol key
    qol-0002
    source section id
    NCT02062632-om-0002
    source outcome index
    2
    instrument
    FACT
    instrument basis
    matched 'factors' in the study's own wording
    scale title
    Use of Alternative Analgesics
    measure definition
    Subgroup analyses will be performed to determine differential effects within the two stratification factors.
    time frame
    Up to 4 hours after treatment
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Only patients who submitted data on alternative analgesics are evaluable for this outcome measure. None of the patients provided information about alternative analgesics, so this secondary outcome could not be analyzed.
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    qol key
    qol-0004
    source section id
    NCT02062632-om-0004
    source outcome index
    4
    instrument
    Patient-reported symptom or function measure
    instrument basis
    matched 'patient reported' in the study's own wording
    scale title
    Incidence of Adverse Events Graded According to Common Terminology Criteria for Adverse Events, Radiation Therapy Oncology Group, and Patient Reported Outcomes (Continuation Phase)
    measure definition
    Means and proportions, along with 95% confidence intervals and plots over time will be reported for adverse event levels by week.
    time frame
    Up to 3 months
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-non-small-cell-lung-cancer-bizengri-c0e986a8
    nct id
    NCT02062632
    qol key
    qol-0006
    source section id
    NCT02062632-om-0006
    source outcome index
    6
    instrument
    Unnamed quality-of-life measure
    instrument basis
    matched 'quality of life' in the study's own wording
    scale title
    Quality of Life Using European Organization for Research and Treatment of Cancer Quality of Life-Lung Cancer 13 and Functional Assessment of Cancer Therapy-Lung
    measure definition
    Comparative statistics will be used to explore the relationship between quality of life and radiation-induced thoracic toxicities. These analyses will include scatterplots, spearman correlations, t-tests and chi-square tests.
    time frame
    Up to 4 hours after treatment
    analysis role
    exploratory
    reporting status
    NOT_POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice